Development of Attention Bias Modification for Depression

Although negatively biased attention has a central theoretical and empirical role in the maintenance of depression, there are few behavioral treatments that successfully target and improve this deficit. The current proposal builds upon prior work and aims to further develop an attention bias modification intervention. The investigators propose to develop a highly specific intervention that directly targets negative attention bias and the neurobiology that supports it, using cutting-edge cognitive neuroscience to inform treatment development and improve quality of life of patients whose psychopathology is maintained by negative attention bias.

Study Overview

• Status: Completed
• Conditions: Depression
• Intervention / Treatment: Behavioral: Attention Bias Modification; Behavioral: Cognitive Control Training

Detailed Description

The overall goal of this project is to continue development of an attention bias modification (ABM) intervention that targets and reduces negative attention bias among adults with elevated symptoms of depression. The investigators' prior work indicates that attention bias for negative information is associated with the maintenance of depression and that neural circuitry within frontal-parietal brain networks supports biased attention for negative information, thus allowing us to develop specific and targeted interventions that directly alter the neurobiology of negative attention bias. The proposed R33 study builds upon the investigators' prior National Institute of Mental Health (NIMH) funded work (R21MH092430), which examined whether ABM reduces negative attention bias and improves symptoms of depression. Findings indicate that compared to placebo ABM, active ABM reduced negative attention bias and increased resting state connectivity within a neural circuit (i.e., middle frontal gyrus and dorsal anterior cingulate cortex) that supports control over emotional information. Further, change in negative attention bias from pre- to post-ABM was significantly correlated with depression symptom change but only in the active training condition. Importantly, a 40% decrease in symptoms was observed in the active training condition; however, similar symptom reduction was also observed in the "placebo ABM" condition. Exploratory analyses indicated that placebo training may have promoted depression improvement by enhancing sustained attention. Although these preliminary findings are encouraging and demonstrate that ABM successfully alters the treatment target (i.e., negative attention bias), the investigators' prior work is among the first to document efficacy of ABM among adults with clinically significant depression. It is now prudent and necessary to obtain additional efficacy evidence for ABM before moving forward with large-scale clinical trials of ABM for depression. Aim 1 is to conduct a randomized clinical trial among adults with elevated symptoms of depression and a negative attention bias that compares the efficacy of active ABM to cognitive control training and an assessment-only control condition that does not involve any ABM procedures. Aim 2 is to examine whether ABM alters negative attention bias and functional connectivity within frontal-parietal neural circuitry that support negative attention bias. Aim 3 is to identify mechanisms responsible for the putative efficacy of active ABM and cognitive control training. Study Impact: The current project proposes to target and reduce negative attention bias with a novel intervention grounded in basic psychopathology research. The investigators believe this experimental medicine approach will lead to the development of a highly specific and targeted intervention, using cutting-edge cognitive neuroscience to inform treatment development, and improve the quality of life of people whose psychopathology is maintained by negative attention bias.

• Study Type: Interventional
• Enrollment (Actual): 145
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Austin, Texas, United States, 78712
      • Mood Disorders Laboratory

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• able and willing to provide informed consent;
• fluent in English;
• moderate or greater depression symptoms;
• attention bias for negative stimuli;
• stable psychiatric and neurological medication usage.

Exclusion Criteria:

• meets criteria for current substance use disorder (mild or greater severity), current or past psychotic disorder, bipolar disorder, or schizophrenia;
• has any medical or physical conditions that would preclude participation in an fMRI study (e.g., orthodontic braces);
• is currently receiving psychotherapy or electroconvulsive therapy (ECT);
• current opioid analgesics or systemic corticosteroid use for an acute medical condition or taken as needed;
• has had suicidal behaviors or significant suicidal ideation within the last six months.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Attention Bias Modification; Behavioral intervention designed to improved negative attention bias.	Behavioral: Attention Bias Modification; Behavioral intervention designed to decrease negative attention bias.
EXPERIMENTAL: Cognitive Control Training; Behavioral intervention designed to improve sustained attention.	Behavioral: Cognitive Control Training; Behavioral intervention designed to improve sustained attention.
NO_INTERVENTION: Assessment Only; Assessment only with no active intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quick Inventory of Depression - Self Report (QIDS-SR)	16-item self-report measure of depression symptom severity	Change in QIDS-SR from baseline to Week 4 to measure change in self-reported depression.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mood and Anxiety Symptoms Questionnaire-Short Form (MASQ-SF)	30-item self-report measure of negative affect symptoms	Change in MASQ-SF from baseline to Week 4 to measure change in self-reported depression.
Hamilton Depression Rating Scale - 17 Item (HAMD-17)	17-item clinician-administered measure of depression symptom severity	Change in HAMD-17 from baseline to Week 4 to measure change in interviewer-rated depression.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Attention bias (eye tracking)	Primary ABM treatment target	Change in attention bias from baseline to Week 4 to measure change in negative attention bias.
Resting State (fMRI)	Resting state functional connectivity	Change in resting state fMRI from baseline to Week 4 to measure change connectivity in frontal-parietal brain circuitry.
Psychomotor vigilance test (PVT)	Behavioral assessment of sustained attention	Change in PVT from baseline to Week 4 to measure change in sustained attention.

Collaborators and Investigators

• Sponsor: University of Texas at Austin
• Collaborators: National Institute of Mental Health (NIMH)

Publications and helpful links

General Publications

• Beevers CG, Clasen PC, Enock PM, Schnyer DM. Attention bias modification for major depressive disorder: Effects on attention bias, resting state connectivity, and symptom change. J Abnorm Psychol. 2015 Aug;124(3):463-75. doi: 10.1037/abn0000049.
• Beevers CG, Hsu KJ, Schnyer DM, Smits JAJ, Shumake J. Change in negative attention bias mediates the association between attention bias modification training and depression symptom improvement. J Consult Clin Psychol. 2021 Oct;89(10):816-829. doi: 10.1037/ccp0000683.

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 1, 2017
• Primary Completion (ACTUAL): September 26, 2019
• Study Completion (ACTUAL): September 26, 2019

Study Registration Dates

• First Submitted: August 17, 2016
• First Submitted That Met QC Criteria: August 22, 2016
• First Posted (ESTIMATE): August 26, 2016

Study Record Updates

• Last Update Posted (ACTUAL): October 16, 2019
• Last Update Submitted That Met QC Criteria: October 14, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder
• Other Study ID Numbers: 201600258; R33MH109600-01A1 (NIH)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified data will be made available upon study completion.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No